Tympanostomy Tube Placement Device and Method for Loading a Tube Thereon

This application a continuation of U.S. patent application Ser. No. 18/071,991 filed Nov. 30, 2022, and entitled, “A Tympanostomy Tube and a Placement Device,” that is a continuation of U.S. patent application Ser. No. 16/757,548 filed Apr. 20, 2020, entitled, “A Tympanostomy Tube and a Placement Device,” and issued as U.S. Pat. No. 11,547,610 on Jan. 10, 2023, that in turn claims priority to PCT Application No. PCT/EP2018/080015 filed on Nov. 2, 2018, and entitled, “A Tympanostomy Tube and a Placement Device,” that in turn claims priority to European Patent Application No. EP3703630A1, filed on Nov. 2, 2017, and entitled, “A Tympanostomy Tube and a Placement Device.” Each of the foregoing cross-referenced applications is incorporated herein by reference.

The invention relates to tympanostomy tubes and placement devices.

When patients are treated surgically for conditions in the ear, for example Otitis Media, they are typically treated by a tympanostomy tube being placed for ventilation. A tympanostomy tube is a small tube which is placed in the tympanic membrane (or “ear drum”) manually by a surgeon, typically under general anesthetic in an operating theatre. The surgeon cleans wax from the ear canal, makes a small incision in the tympanic membrane, uses suction to remove any fluid in the middle ear, and then positions the tube in the tympanic membrane. The tube equalizes the pressure between the middle and outer ear and ventilates the middle ear space. Tympanostomy tube placement is the most common reason why children undergo surgery with a general anesthetic.

At present, when it is desired to place a tympanostomy tube, it is typically done manually because the inner flange needs to be particularly wide to stay in the tympanic membrane for an extended period of time. The tympanostomy tube sometimes requires a lead-in feature on the inner flange of the tube to aid insertion of the manual placement using current ENT instrumentation.

A placement device allows tympanostomy tubes to be placed safely and quickly in a clinical setting, allowing tubes to be placed without the need for general anesthesia in all patients.

WO2013/155169 (Acclarent) and U.S. Pat. No. 4,744,792 (Richards Medical Co.) describe tympanostomy tubes.

WO2011/008948 (Acclarent) describes a tympanostomy tube and a placement device wherein the tip creates an incision in the tympanic membrane and ejects a tympanostomy tube into the membrane. A tympanostomy tube is restrained by sleeves surrounding it so that its flanges lie axially. The sleeves are withdrawn during deployment to allow the flanges to un-fold to the radial position.

WO2013/113022 (Entra Tympanic LLC) describes a placement and removal device which has vacuum channels to immobilize the membrane during the tube placement. In this case the tube's flanges are not folded, the tube retaining the same physical configuration throughout.

The invention is directed towards providing a placement device for effective deployment of a tube, especially a tube having a wide distal flange for a long dwell time or “time to extrusion”. The time to extrusion is dependent on the clinical requirement of the patient.

A tympanostomy tube placement device has a stem with a needle having a tip configured to pierce a tympanic membrane. A retainer is on the needle and comprises fingers extending axially at a distance from said axis and equal circumferential separations in one example. The retainer is movable from a distal position at which it presses radially inwardly against the tube distal flange tabs to retain the distal flange in a folded position, to a proximal position at which the tube distal flange is free to spring out radially to a deployed position. The retainer fingers extend through tube proximal flange passageways and press the tube distal flange inwardly, while leaving a distally-facing face of the proximal flange exposed radially outwardly of the retainer. Hence, the proximal flange has its final deployed configuration throughout, and so can act as a physical stop member against the tympanic membrane and also provides visualization for the surgeon because it extends radially outwardly of the stem.

In various aspects we describe a tympanostomy tube placement device comprising:

Preferably, there are at least two diametrically opposed retainer fingers. Preferably, the fingers have an arcuate cross-sectional shape with a concave internal surface.

The device may further comprise a handle connected to the stem, and the stem may be rotatable with respect to the handle, and there may be a user actuator for rotation of the stem. Preferably, the needle is lockable in the stem so that it rotates with the stem. Preferably, the needle comprises a lock member for engagement within a recess of the stem. Preferably, the stem is cranked or bent along its length.

Preferably, the placement device further comprises:

Preferably, the tube distal flange comprises at least one tab aligned in circumferential position with a retainer finger and being pressed inwardly by said finger in the pre-deployed position.

Preferably, the distal flange comprises a plurality of tabs.

Preferably, the tabs are substantially equally circumferentially spaced. There may for example be four tabs, spaced apart by approximately 90°. Preferably, the passageways are through holes, each having a surface facing radially inwardly and engaging an outer surface of a retainer finger. Preferably, at least one through hole has an arcuate shape and said surface is concave. There may be at least one pair of diametrically opposed passageways.

The tube proximal flange may be of a first material and the distal flange may be of a second material, and said first material is more rigid than the second material.

Preferably, the retainer or the needle comprises an axial guide member configured to fit in the lumen of the tube pre-deployment.

The needle may comprise a recess proximally of the tip and configured to receive a folded-down part of a tab of a tube distal flange. Preferably, the recess () is annular. Preferably, the needle and the tube distal flange tabs are configured to form an arrow shaped formation when the distal flange is folded down.

In another aspect, we describe a tympanostomy tube comprising a proximal flange, an inter-flange connector with a lumen, and a distal flange, wherein the proximal flange comprises a plurality of axial through hole passageways and the distal flange is configured to be folded axially to a deployment position and to release radially to a deployed position.

Preferably, at least one passageway has a radially inner surface which is adjacent an external surface of the inter-flange connector. Preferably, said radially inner surface is curved. Preferably, the passageway has an arcuate shape with an outer concave surface facing radially inwardly. Preferably, there is at least one pair of diametrically opposed passageways. Preferably, the distal flange is more flexible than the proximal flange.

The proximal flange may be of a first material and the distal flange is of a second material, said first material being more rigid than the second material.

Preferably, the distal flange comprises a plurality of tabs at least one of which has a radial part extending in a direction which has a primarily radial component and a guide part extending in a direction which has a primarily axial component when the tube is relaxed, and the guide part is arranged to form a tapered configuration narrowing in the distal direction when the distal flange is pressed radially inwardly.

We describe a tympanostomy tube comprising a proximal flange, an inter-flange connector with a lumen, and a distal flange, wherein the proximal flange comprises a plurality of axial passageways and the inner flange is configured to be folded axially to a deployment position and to release radially to a deployed position.

Preferably, the passageways have a radially inner surface which are adjacent an external surface of the inter-flange connector. Preferably, the passageways are through holes.

Preferably, the through holes have an arcuate shape with a concave surface facing radially inwardly. Preferably, there is at least one pair of diametrically opposed passageways.

The proximal flange may be of a first material and the distal flange is of a second material, and said first material is more rigid than the second material. The first material may be a metal, and the second material a polymer. The inter flange connector may be integral with the distal flange. The tube may be co-molded of different materials.

We also describe a tympanostomy tube placement device comprising a stem connected to a deployment mechanism or having a coupler for connection to a deployment mechanism, and a needle having a tip configured to pierce a tympanic membrane, the needle having a longitudinal axis. The device may have a retainer comprising a plurality of fingers extending axially at a distance from said axis. The retainer may be movable from a distal position at which it is adapted to press radially inwardly against a tube distal flange to retain said distal flange in a folded position, to a proximal position at which a tube distal flange is free to spring out radially to a deployed position.

Preferably, there are at least two diametrically opposed retainer fingers, for example two pairs of opposed fingers.

Preferably, the fingers have an arcuate cross-sectional shape with a concave internal surface.

The device may further comprise a handle.

Preferably, the stem is rotatable with respect to the handle. Preferably, the device further comprises a user actuator for rotation of the stem.

Preferably, the needle is lockable in the stem so that it rotates with the stem. The needle may comprise a lock member for engagement within a recess of the stem.

Preferably, the stem is cranked or bent along its length.

We also describe a tympanostomy tube placement device further comprising a tube of any embodiment, with the retainer fingers extending through the tube proximal flange passageways and pressing the tube distal flange inwardly, while leaving a distally-facing face of the proximal flange exposed radially outwardly of the retainer. Such a device preferably has the tube factory-inserted in position so that the device is ready for use upon opening of its package. Preferably, the tube distal flange comprises a tab aligned in circumferential position with a retainer finger and being pressed inwardly by said finger.

Referring toa tympanostomy tubecomprises an inter flange connectorwith a lumenfor crossing through a tympanic membrane. The inter flange connectorconnects an outer (proximal) flangeand an inner (distal) flange.

The proximal flangeis generally circular around its periphery, with an annular shape. It has a generally annular facefacing distally, towards the tympanic membrane in use.

The distal flangeis around the lumenat its distal end and comprises four circumferentially spaced-apart tabs, at 90° to each other.

The proximal flangeincludes four passageways, in this case arcuate through holesaround the periphery of the inter flange connector, and are equally spaced apart. The passagewaysare axially and circumferentially aligned with the tabsof the distal flange, being also at 90° to each other. Each passagewayhas a radially-inwardly facing curved surface.

In various examples, the passageways are preferably through holes such as the passageways, and they preferably have an arcuate shape with a concave surface facing radially inwardly, as shown.

Referring toa placement devicecomprises a needlehaving a stemand a tip. The needleextends centrally through a sleeveof a stemof the device. The needle stemis in turn connected to a user-actuated deployment mechanism within a handle, not shown, proximally of the device stem. The mechanism is arranged to pull the needleback in the proximal direction upon user pressing of an actuator button. This mechanism may be of any known type for user-actuated retraction, preferably spring-loaded for release of spring pressure to cause retraction.

shows the tubeoutside of the placement device, for clarity.

A retaineris mounted to the needleby connection to a central bodyof the needle stemby welding, or in other embodiments by a press-fit feature, or being integral, for example. The retainercomprises four axially-extending fingers, equally spread circumferentially with 90° separations. The fingers are configured with cross-sectional shapes very slightly smaller than those of the tube passageways. They extend from a retainer baseon the needle stem and through the tube arcuate passagewaysin use. A central guideis also part of the needle, within the volume encompassed by the fingers. The retainer, specifically its fingers, is for holding the distal flangeaxially for visualization of the needle tip and to reduce the profile for insertion through the tympanic membrane in use, as described in more detail below with reference to.

shows more clearly the stemand the tipof the needle, with the central guidewithin the retainer fingers. The retaineris clearly illustrated, with the fingersextending axially. The configuration of the central guideallows it to fit within the lumenof the tubein use during placement. This provides a guiding effect for accurate location and movement of the fingers relative to the tube.

As shown in, the device stem sleevereceives in its mouththe retainer, the needle, and a lock memberwhich is an integral part of the needle. In use, it may be beneficial to rotate the sleevein order to improve the angular orientation of the stem in relation to the membrane. Due to the lock membersuch rotation causes the needleto rotate with the stem. The lock memberis of rectangular block shape for fitting into the sleeve mouth, also of rectangular cross-sectional shape. When this is engaged in the recessit prevents the needleand the attached retainerfrom rotating. The angled or cranked stem sleeve, as shown in, is also to aid visualization.

In other embodiments the locking of the needle to the stem may be by way of any other suitable feature such as a snap-fit fastener, possible in the configuration of a dimple for example.

As is illustrated in, before deployment, the retainer fingerspass through the proximal flange, surround the inter-flange connector, and radially push in the (folded) distal flange. The fingersradially push in the tabsof the distal flangeto an extent that the distal end of the tubeand the needle tipcan easily penetrate the tympanic membrane in use. The proximal flangeadvantageously has its final in-use position at which it resists movement through the tympanic membrane, while the distal flangecan be easily pushed through because it is retained substantially axially by the fingers, the distal flangetabsbeing pressed radially inwardly.

In more detail, in use the tubeis mounted to the deviceeither manually at the point of use or is pre-mounted in the factory. The placement deviceis moved by the surgeon so that the stementers the ear canal and the needle tippierces the tympanic membrane. Advantageously, the faceof the proximal flangeabuts the tympanic membrane even though the distal flangeis folded. This provides an accurate and simple limit to insertion of the stem. The tube proximal flangeextends radially beyond the distal surface of the sleeve, and as it abuts the tympanic membrane, it provides a reference point for visualization when in use. The proximal flangetherefore acts as a limit to insertion, allowing the surgeon to know when the myringotomy knife (needle)has been inserted far enough through the tympanic membrane and to release the tubefrom the device. It is envisaged that, in other embodiments, the sleevemay have a radial dimension which is even smaller relative to that of the proximal flange than illustrated.

Importantly, the fingersradially push the distal flange tabsinwardly so that they can easily pass through the tympanic membrane. However, because the retainer fingerspass through the proximal flangethe latter can easily be maintained proximally of the membrane, with its faceabutting the membrane and acting as a limiting stop. This allows much more accurate positional control than is the case with prior art devices.